Citing “vague and inconsistent” federal reporting standards, Ohio will require drug distributors to report and halt suspicious orders of prescription painkillers in hopes of further reducing opioid addiction and deaths.
The state’s proposed rules, expected to take effect in three to four months, would require drug distributors to detect — and not ship — suspicious orders of opioids to pharmacies and hospitals, such as orders that are large when compared to past purchases.
Ohio Board of Pharmacy officials and Gov. John Kasich outlined the proposal at a Thursday press conference at the Statehouse while admitting much still needs to be done to rein in street sales of opioids fueling an ever-increasing number of overdose deaths.
The more than 500 state-licensed drug distributors and wholesalers will be required to report more-detailed information to the state for analysis to flag distributors and pharmacies that may attempt to sidestep the new rules. Violations could lead to the loss of distributors’ state license.
The rules, which are being posted for public comment and feedback from distributors, would deem any opioid order in excess of 5,000 doses a month as suspicious and require further scrutiny.
A Cardinal Health, based in suburban Columbus, is one of the country’s largest distributors. A spokesman said in a statement, “We look forward to working with the governor and Board of Pharmacy on these important rules. We take our role in the supply chain seriously and as such we operate a state of the art system to prevent the diversion of opioids from legitimate medical use.”
Reporting requirements for pharmacies and physicians and limits on opioid prescriptions have reduced the amount dispensed by 20 percent from 2012 to 2016 while also reducing deaths, but the availability of street drugs, particularly deadly fentanyl, remains alarming, Kasich said.
“The time has come for our communities to work to kill this devil that lurks on our streets, in our schools and in our communities,” the governor said of illicit opioid sales.
Drug overdoses, largely from opioids, killed 4,329 people in Ohio in 2016, a 24-percent increase over 2015 and the second-highest death rate in the nation, according to federal figures.
Many officials expect the 2017 total to be even higher.
As part of the battle to fight opioid abuse and availability, a law that took effect Sept. 1 placed limits on the pain-pill prescriptions written by Ohio physicians, dentists and others. The new requirements limit patients to a seven-day supply of opioids — five days for minors — for the treatment of short-term pain. Refills can be prescribed only if physicians or other medical professionals document the need for extending pain-relief medication.
Prior to the law, voluntary guidelines cut the number of overdose deaths from opioid prescriptions from 667 in 2015 to 564 in 2016. State officials say 80 percent of those who died from drug overdoses in 2016 previously had received legally prescribed opioids.
Joined by several cities and counties in separate actions, the office of Attorney General Mike DeWine is suing five drug manufacturers for improperly peddling and profiting from opioid sales. Talks have started with some of the companies about a potential settlement to generate funds for opioid education and treatment.
DeWine has indicated he may sue drug distributors, but still is reviewing the matter, spokesman Dan Tierney said.
The attorney general was “encouraged” after attending a hearing in federal court in Cleveland on Wednesday before a judge working to broker a settlement of more than 200 opioid-related lawsuits filed by counties and municipalities against drug manufacturers and distributors.
“While our office is confident we will prevail in our lawsuit should it proceed to trial in Ross County, the process underway in federal court in Cleveland is notable in that it is seeking to provide substantive help to governments dealing with the opioid epidemic through reaching a settlement sooner,” Tierney said.